FDA 483 - Bonafix Surgical and Dental Implants, LLC - March 11, 2019

An FDA inspection of Bonafix Surgical and Dental Implants, LLC in Delray Beach, FL, revealed significant quality system deficiencies. The firm failed to validate design under defined operating conditions, including issues with bioburden assessment for dental implants. Additionally, the inspection found inadequate evaluation and selection of suppliers and contractors, with repeat observations from a previous inspection, and a failure to adequately review and investigate product complaints.